FDA Law Blog

JULY 17, 2024

This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. According to FDA, the new Hub will have special focus on products intended for smaller populations and also for diseases where the natural history is variable and not fully understood.

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FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

Manufacturing 71

Manufacturing Management Specialization Provider 71

Vascular Physician

OCTOBER 26, 2021

What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. The chambers are about 3 feet in diameter and 8 feet long, so they are big enough for people to enter and exit easily.

Patient-Centered 52

Patient-Centered Diabetes Treatment Plan Insurance 52

FDA Law Blog

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The public may harbor similar doubts, leading prosecutors to avoid putting Park cases before juries.

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Private Practice Government Individual Specialization 59

Vascular Physician

OCTOBER 10, 2022

Hyperbaric oxygen therapy is a type of treatment that involves a person lying in a special chamber with air pressure that is up to three times higher than normal air pressure. What is Hyperbaric Oxygen Therapy?

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Consulting Specialization Diabetes IT 52

Vascular Physician

FEBRUARY 23, 2020

Vascular Institute of the Rockies 5-7 years of training after medical school specializing in learning about all aspects of peripheral vascular disease. Because vascular surgeons have the skills to provide every treatment of vascular disease, they can help individualize the treatment of each patient to what will work best for them.

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Referral Management Complication Specialization 40

The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. However, I so commonly see individuals inflate their lifestyle by overextending themselves when buying a home.

Finance 52

Finance Insurance Individual IT 52

Reflections of a Grady Doctor

JUNE 30, 2022

One distinctly different and special from the one you had with him as a child—and unique to you and no one else? And especially thank you for the gift of showing up in every aspect of our lives—physically, emotionally, financially, collectively, and individually. We will forever speak your name and rejoice in your legacy.

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IT Relationship Specialization Physicals 52

FDA Law Blog

MARCH 2, 2022

The revised immediately effective guidance states that products categorized as “household substances” and only intended for institutional use must be sold in special packaging under the PPPA guideline. Yet, as CPSC acknowledges, the PPPA requires certain household substances to be packaged in accordance with special packaging standards.

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Specialization Individual IT Provider 52

GeriPal

MAY 19, 2022

As I’ve been blogging about this for a couple months now, I’m really trying to find anyone who loves these things. Drew: I’ve published a draft version of it on the blog. And then again, individualizing it to the patient. Eric: Drew, both of our fourth step is individualizing it. It’s compacted.

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IT Patients Individual Relationship 139

FDA Law Blog

MARCH 7, 2024

Among the forty or so individuals invited to this White House event were long-time rare disease advocates like recently retired FDA Principal Deputy Commissioner Janet Woodcock, Christina Hochul of Alexion and Paul Melmeyer of Muscular Dystrophy Association. It was a highlight of my career to also be invited to this historic event.

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Government Community Specialization Education 69

Aspiring Minority Doctor

JUNE 18, 2023

Now don't get me wrong, I am legitimately happy for all these individuals and I love seeing their success, especially when I know how hard the struggle is. I've always stayed positive on this blog, but I never did enjoy my time in my previous program.

Medical Student 52

Medical Student Medical IT Internal Medicine 52

FDA Law Blog

JULY 12, 2022

On June 30, individuals with access to the CCP (i.e., The email also states that the ability to submit completely electronically will first be offered to individuals with CCP accounts so that CDRH can assess the platform’s performance. the only submission type currently trackable via the CCP).

Electronics 52

Electronics Individual Specialization Physicals 52

FDA Law Blog

MARCH 16, 2023

This device is indicated for the following use: for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., In the best tradition of teasers, keep reading our blog.

Healthcare Professional 40

Healthcare Professional Specialization Transportation Diagnosis 40

FDA Law Blog

FEBRUARY 18, 2025

The discussion of the Agencys expectations of the form and substance of expert witness testimony is a must-read for entities or individuals facing a DEA order to show cause hearing. Finally, the decision explores DEAs current thinking on a pharmacists corresponding responsibility when resolving red flags. In Neumanns Pharmacy, LLC , 90 Fed.

Government 69

Government Specialization Patients IT 69

FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). The draft guidance outlines some of the practical considerations for DCTs with regard to recordkeeping and clinical trial operations.

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Clinic Telehealth Provider Electronics 59

FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. an administrative appeal) under 21 CFR 10.75

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). 3, 2020).

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

MAY 8, 2023

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

MAY 7, 2025

As such, neither Sorensen nor the entities he paid had any authority to act on behalf of a physician or unduly influence[d] the doctors decisions.

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Referral Relationship Government Healthcare 59

FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. They also review CSOS transactions for completeness and accuracy.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. They also review CSOS transactions for completeness and accuracy.

Management 40

Management Consulting Provider Physicals 40

Aspiring Minority Doctor

FEBRUARY 7, 2023

It made me feel so special and loved. Even cooler, the photographer took individual headshots of us that will be able to use for branding or however we like. This actually took the entire 4 hours, but it was such a beautiful display of gratitude, and I really loved it. It was such a beautiful gift.

IT 52

IT Medical Mental Health Patients 52

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},". Food has the power to regenerate the new you!

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Referral DO Family Medicine Primary Care 40

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Dr. Johnson noted that the ABIM Council considers issues that affect multiple disciplines and how to address them in public forums, while the Specialty Boards can individually choose to address issues specific to their disciplines. The following is a summary of the spring meeting.

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Board-Certified Government Community Education 52

GeriPal

FEBRUARY 29, 2024

Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. I actually wrote a blog post about this when we were a blog. We were a blog? I’m most proud that when we started the blog, there was some tension between Geriatrics and Palliative care. Alex: Okay.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

AUGUST 31, 2023

He studies the mental health system in the ways in which it has failed children and adolescents, and he writes about his experience with cancer in a blog, the Billgardner.substack.com, Billgardner, one word. ” Somebody in the comments on their blog response said, “Did you check the date? Bill: Thank you. Brad: Thank you.

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Illness IT Diagnose Medical 128

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. So my special guest host on this episode is a trainee in pediatrics and medical genetics. In other words, which features of the disease individuals with the mutation show for these conditions.

Consulting 59

Consulting Individual Family Families 59

GeriPal

APRIL 14, 2022

We got some really special guests with us. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. And so that lends it properties of being a pretty strong analgesic and it lends its special properties for safety, from a safety profile.

Illness 102

Illness Patient-Centered IT Patients 102

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 30, 2023

I started blogging as a patient, just talking about my own story online like patients did back in the day. I was like maybe I’ll write a blog post about this later. I’m going to try to remember as much as I can, so when I wake up, can I write a … My thought was I’m going to write a cool blog post about this.

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IT Patient-Centered Patients Healthcare 96

GeriPal

SEPTEMBER 22, 2022

There’s no special thing to say, but sometimes we’re tempted to treat serious illness communication in that way, conversational judo or something, that I can maneuver around an encounter and create something new. All these studies in this fringe… We want the special key. Not a lot of blogs out there.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

JUNE 29, 2023

This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. I am there with individuals who are dying.

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IT Family Families Board-Certified 97

GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. Eric: And for our audience, if they can’t tell, there’s a theme here.

IT 105

IT Healthcare Professional Healthcare Transportation 105

FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” at § 387g(d)(2). How will the flavored cigar ban affect premium cigars?

IT 52

IT Manufacturing Specialization Community 52

FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” at § 387g(d)(2). How will the flavored cigar ban affect premium cigars?

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IT Manufacturing Specialization Community 40